CRISPR is a gene editing technique that promises to revolutionize genetic engineering, but already is raising ethical, business, and legal issues. This is the first in a monthly series of articles on CRISPR. If you are interested in more information, please download a digital copy of our web conference on “Navigating the CRISPR Patent Landscape and Business Impact” or contact any of the authors.
Implementing unique litigation tactics, on June 15, 2016, Foley & Larder LLP filed a complaint under Section 337 of the Tariff Act at the International Trade Commission (“ITC”) on behalf of Par Pharmaceutical and related parties (Par as “Complainants”). The complaint, which is grounded in allegations of the unlawful importation of certain Potassium Chloride powder products into the United States, sale for importation, and/or sale after importation, seeks a permanent limited exclusion order and a cease and desist order against Viva Pharmaceutical Inc., a Canadian company, Virtus Pharmaceuticals, LLC, a Florida-based company, and Virtus Pharmaceuticals OPCO II, LLC, a Tennessee-based company (collectively, “Virtus”) (all together, “Respondents”), in addition to their respective agents and related companies. While 337 complaints alleging patent infringement, copyright infringement, and trademark infringement are common, this is the first 337 complaint based on the unfair act of a competitor’s marketing of an unapproved drug.
3D printing offers great promise for innovation and manufacturing, but this tool has expanded the scope of patented products that can be easily and cheaply copied, and may make it harder to identify and prosecute infringers. The USPTO held a conference on legal and policy issues surrounding 3D printing on June 28, 2016. Oyvind Dahle, a summer associate at Foley & Lardner LLP, attended the conference and contributed to this article highlighting some of the points that were discussed. Continue reading this entry
In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before commercial marketing begins.” The court dismissed concerns that its holding would extend the originator’s 12-year exclusivity period by 6 months, reasoning that the FDA could signal approval of a biosimilar before the 12-year exclusivity period has run, but is that correct?
In an en banc decision issued in The Medicines Company v. Hospira, Inc., the Federal Circuit determined that in order for a commercial transaction to trigger the on-sale bar of § 35 USC 102(b), it must “bear the general hallmarks of a sale pursuant to Section 2-106 of the Uniform Commercial Code.” Unlike the three-judge panel who first decided the case in July 2015, the full court determined that the contract manufacturing transaction for commercial quantities of Angiomax® did not rise to that level, and so affirmed the district court’s holding that it did not trigger the on-sale bar.